Better (regu) late than never...but watch out, it's GE!

A critique of the BRAI bill by Shalini Bhutani

The Biotechnology Regulatory Authority of India (BRAI) Bill surfaced quietly in the List of Business for Lok Sabha in August 2011. It did not however make it for introduction in this session of Parliament. Yet the din about it outside the legislature refuses to settle down.

The Bill once again sets off discussions in India on what a regulatory regime for modern biotechnology in the country ought to be like. If the Authority does see the light of day, it would do so after the very first decade (2002-2012) of India's experience with GE crops. So one way to view the Bill is to see if its provisions address at least some of the concerns raised by people based on these years of real encounters with GE technology per se and the decision-making processes on it. Also, it is to be seen if the latest version actually improves upon the previous version of the BRAI Bill (2009).

The need to revamp the country's regulatory regime on biosafety is being raised by people since the 90s. That was when the first 10 grams of Bt – proprietary material of the MNC Monsanto Inc., was brought into the country from the US. And that's precisely the problem. The country exporting the technology and pushing for its application in agriculture, does not adhere to any global biosafety agreements and on the contrary attempts to influence the kind of regulatory regime our country ought to have on GE.

In 2003 the global Cartagena Protocol on Biosafety (under the Convention on Biological Diversity came into force. In the very same year in India a Task Force on the Application of Agriculture Biotechnology was constituted by the Ministry of Agriculture. As mentioned in the Statement of Objects and Reasons of the Bill (2011), the Task Force recommended (2004) the establishment of an “autonomous, statutory and professionally-led National Biotechnology Regulatory Authority”.

But on the side the US-India Business Council and its members, as well as the USAID through its support programmes on biosafety come to bear on the issue. In this context it is pertinent to note that the scope of the Bill does not cover export of GE from India at all! The opening words of the Bill mention that the BRAI is to regulate research, transport, manufacture, use and import of GE organisms and products. But the term 'export' in the preamble and the rest of the text is conspicuous by its absence.

One of the key concerns vis-a-vis biosafety has been the lack of an independent authority to oversee the approval process for the application of biotechnology. The Bill sets up a five-member Authority with a Chairperson with two full time and two part time 'members'. The Bill makes specific mention of financial or other conflict of interest that has to be considered at the time of appointment. And a member can not hold another position be it in the Government – Centre or State, another organisation or a private company, while in office. Even upon leaving office, a member is debarred from certain positions for a period of two years.

All BRAI members are to be appointed by the Central Government through a Selection Committee. The Authority is to be overseen by an Inter Ministerial Governing Board and a Biotechnology Advisory Committee, both of which are also comprising Central Government officials. Agriculture is a State subject as per the legislative distribution of powers. So merely having an advisory body at the State level – the State Biotechnology Regulatory Advisory Committees (SBRAC) will not tip the balance in favour of localised decision-making. There is no mention of any District level committees as are supposed to exist under the existing GE Rules (1989 issued under the Environment Protection Act, 1986). In fact by virtue of the BRAI Bill, any State law in force on the subject would also stand repealed.

The linkage with other laws (Section 81) states the overriding effect of the law-to-be. But Section 86 instead states that the provisions of this Act will be in addition to and not it derogation of any other law for the time being in force. This contradiction has to be resolved. The only other law that talks of biosafety, is the Biological Diversity Act (2002) of India. The said Act makes it mandatory for the Central Government to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology likely to have adverse impact on the conservation and sustainable use of biological diversity and human health.

The Bill however resolves at least for the Central Government the dilemma on which Ministry ought to have the last word on decisions on the application of GE. The choice is clearly in favour of the Ministry dealing with science and technology. The Bill thus significantly reduces the say of the Environment Ministry. Of course the BRAI would replace the GEAC, thus far has been under the Environment Ministry. But the Bill makes clear the relationship between the BRAI with the MoEF. The Bill unlike its 2009 version envisages an Environment Appraisal Panel (EAP), with a Chairperson, five members and a Member Secretary located in MoEF. It is mandatory for the BRAI to obtain the opinion of the EAP, but is not bound by it!

The Bill is a carve-out from the coverage of the right to information law in India. While it can be understood why any BRAI member is debarred from disclosing to any third person any matter currently under consideration of the BRAI. But there are strictures against the disclosure of confidential commercial information. With more and more aspects of modern biotechnology (processes and products) being brought under intellectual property (IP) coverage, IPR can become a veil to hide behind. And in what can only be read as a deft political move, the text of the Bill makes it the responsibility of the SBRAC to ensure that information of the BRAI and its activities are made available to the public in a transparent and accessible manner in the State [Section 35(6)(e)].

How people participate in the decision-making is another crucial issue. BRAI is mandated to obtain the objections or suggestions from the public; but the letter of the law does not indicate that it is bound by them. Actual practice has shown otherwise. Also people protesting against GE in agriculture were outraged by a Section 63 in the earlier version of the BRAI (2009) Bill, which made it a punishable offence (6 months to 1 year prison with fine upto two lakh rupees) to “mislead(s) the public about the safety of the (GE) organisms and products”. Though that section has been done away with, but farmers and activists opposing GE may still find themselves on the wrong side of the law if they either provide any false or misleading information (Section 62) or if they attempt to obstruct any official discharging any function under the Act (Section 64).

Both the Bills talk of the Central Government setting up a Biotechnology Regulatory Appellate Tribunal (BRAT) that will have the power to regulate its own procedure and would function like a civil court. Thus the bar on jurisdiction on all civil courts on any matter that the BRAT is empowered to deal with. So an entire new parallel quasi-judicial structure is envisaged as part of the regulatory regime.

Yet the jury is still out on the safety of the technology sought to be regulated under the BRAI Bill. That in itself is a fundamental issue to address. As is said, no technology is neutral. (Particularly, if it emanates from the USA.) And in India we are yet to democratise any of our regulatory regimes. Today it is GE, tomorrow there will be nanotechnology et al, will a whole new Bill and with it an other technocracy then emerge?

About the author - Shalini Bhutani

Shalini is a lawyer based in Delhi, India. She is working independently on issues of trade, agriculture and biodiversity. She has worked in several national and international NGOs in the last fifteen years including the Centre for Environmental Law at WWF-India, Navdanya and GRAIN. Currently along with others in India she is involved in the Campaign for Conservation and Community Control over Biodiversity. She is also part of the Forum Against FTAs in India. In the Asia region she is also associated with Pesticide Action Network Asia Pacific.